Beneficial Exposome Study

Beneficial Exposome: Investigating Its Effect on Human Health

The purpose of this study is to explore the positive, holistic health outcomes resulting from regular exposure to naturally occurring compounds predicted to have health benefits. The researchers hope to learn how the human body is influenced by regular exposure to these compounds.

Study Overview

• Status: Recruiting
• Conditions: Healthy
• Intervention / Treatment: Other: Natural Compound A (Hinoki essential oil); Other: Natural Compound B (Lemon essential oil); Other: Natural Compound C (Control/Water)

Detailed Description

Considerable research has been conducted on the effects of environmental exposure on human diseases. This is also known as "exposome" research. However, there is limited research on the impact of beneficial exposomes found in the natural environment. The researchers would like to identify and measure the benefits of these naturally occurring compounds on holistic human health.

Through blood specimens, the researchers will observe biomarkers such as cortisol levels and inflammatory markers. Data will be collected from wearable sensors to observe the effects of beneficial exposomes on areas such as cardiovascular health and sleep quality. There will be surveys to understand well-being, stress, and mood. Through such observations, this study aims to understand the positive impacts of intentional exposure to selected compounds found in nature.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Allison Zhang, PhD; Email: zhangxy@stanford.edu
• Study Contact Backup: Name: Ji Hyun Kim, MS; Phone Number: (650) 441-6216; Email: jikimji@stanford.edu

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Recruiting
      • Stanford University
      • Contact: Ji Hyun Kim, MS; Phone Number: 650-441-6216; Email: jikimji@stanford.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 18 years of age and older
• Read, speak, and understand English
• Live in the US territory

Exclusion Criteria:

• Mental incapacity and/or cognitive impairment on the part of the patient that would preclude adequate understanding of, or cooperation with, the study protocol
• Is pregnant
• Is breastfeeding
• Has epilepsy
• Has allergies to Cupressaceae family of plants, common plants include redwoods, junipers, cypress, cedar, fir, and sequoia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group A- Natural Compound A to Natural Compound B to Natural Compound C; Cycle 1 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping; Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period); Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping; Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period); Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping; Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.	Other: Natural Compound A (Hinoki essential oil); Participants will use "Natural Compound A" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).; Other: Natural Compound B (Lemon essential oil); Participants will use "Natural Compound B" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).; Other: Natural Compound C (Control/Water); Participants will use "Natural Compound C" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).
Experimental: Group B- Natural Compound B to Natural Compound C to Natural Compound A; Cycle 1 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping; Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period); Cycle 3 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping; Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period); Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping; Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.	Other: Natural Compound A (Hinoki essential oil); Participants will use "Natural Compound A" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).; Other: Natural Compound B (Lemon essential oil); Participants will use "Natural Compound B" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).; Other: Natural Compound C (Control/Water); Participants will use "Natural Compound C" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).
Experimental: Group C- Natural Compound C to Natural Compound A to Natural Compound B; Cycle 1 (4 weeks): use diffused "Natural Compound C" (control) in a diffuser every night when sleeping; Cycle 2 (4 weeks): will not use compounds/diffuser (wash-out period); Cycle 3 (4 weeks): use diffused "Natural Compound A" (essential oil) in a diffuser every night when sleeping; Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period); Cycle 3 (4 weeks): use diffused "Natural Compound B" (essential oil) in a diffuser every night when sleeping; Cycle 4 (4 weeks): will not use compounds/diffuser (post-intervention observation period) There will be 3 natural compounds; the intervention compounds essential oils and are commercially available and there is a control compound (water). They will be used as intended with diffusers.	Other: Natural Compound A (Hinoki essential oil); Participants will use "Natural Compound A" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).; Other: Natural Compound B (Lemon essential oil); Participants will use "Natural Compound B" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).; Other: Natural Compound C (Control/Water); Participants will use "Natural Compound C" in a diffuser every night for 4 weeks. Diffuser will be placed near participant's bed and will be used during the entire time they are asleep (about 8 hours, every night).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Resting Heart Rate	Change in resting heart rate measured by wearable devices	Baseline; 26 weeks
Heart Rate Variability	Change in resting heart rate measured by wearable devices	Baseline; 26 weeks
Change in sleep quality measured as duration of sleep stages	Duration of each sleep stage [i.e. light, deep, rapid eye movement (REM), wake stages] overnight. Sleep quality will be measured via a wearable device. Sleep quality will be compared to baseline through the other intervention phases.	Baseline; 26 weeks
Profile of Mood States	Change in mood states, a 65 item scale that allow for the quick assessment of transient, fluctuating feelings and enduring affect states.	Baseline; weeks 2, 6, 10, 14, 18, 22, and 26

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Metabolome	Change in personal metabolic states as measured in microsampling by targeted and untargeted metabolomics-- liquid chromatography mass spectrometry (LC-MS)-- compared to baseline through the other intervention phases. Dry blood samples will be collected by microsampling bi-weekly at a consistent time in the morning. Based on those samples, metabolomics (e.g., short-chain fatty acids, amino acids and other polar and nonpolar metabolites) will be extracted and quantified by LC-MS.	Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Proteome	Comparison of protein changes measured in biospecimens obtained through microsampling against baseline values across various intervention phases. Dry blood samples will be collected by microsampling bi-weekly at a consistent time in the morning. Based on those samples, proteomics will be quantified by proximity extension assay for the cardiometabolic panel. 96 proteins will be measured in the unit of normalized protein expression.	Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Transcriptome	Change in messenger ribonucleic acid (mRNA)-based expression measured in biospecimens compared to baseline through the other intervention phases.	Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Well-being	Change in well-being measured by Five Well-Being index, a 5-item scale providing a 0 - 25 point composite score, with higher scores indicating greater well-being.	Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26
Perceived Stress	Change in perceived stress measured by Perceived Stress Scale-10, a 10-item scale providing a 0-40 point composite score, with higher scores indicating greater perceived stress.	Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Generalized Anxiety	Change in anxiety presence and/or severity measured by Generalized Anxiety Disorder-2, a 2-item scale providing a 0-6 point composite score, with higher scores indicating greater anxiety.	Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Depression	Change in depression presence and/or severity measured by Patient Health Questionnaire-2, a 2-item scale providing a 0-6 point composite score, with higher scores indicating greater severity	Baseline; weeks 2, 6, 10, 14, 18, 22, and 26
Inflammation Profile	Comparison of inflammatory marker changes measured in biospecimens obtained through microsampling against baseline values across various intervention phases. Dry blood samples will be collected by microsampling bi-weekly at a consistent time in the morning. Based on those samples, inflammatory markers will be quantified by targeted 96 Inflammation panel.	Baseline; weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, and 26

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Michael Snyder, PhD, Stanford University

Study record dates

Study Major Dates

• Study Start (Actual): April 16, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: October 4, 2023
• First Submitted That Met QC Criteria: October 16, 2023
• First Posted (Actual): October 23, 2023

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: November 30, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Anti-Inflammatory Agents; Corticosterone
• Other Study ID Numbers: 71135

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No current plan to share data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No